Correlation of Brain and Thenar Muscle Oximetry During Cardiac Surgery With Parameters of Acute Kidney Injury

Correlation of Brain and Thenar Muscle Oximetry During Cardiac Surgery With Parameters of Acute Kidney Injury in Adult Cardiac Surgical Patients Operated on Cardiopulmonary Bypass

Identification of risk factors of acute kidney injury (AKI). It is hypothesized that there might be a correlation between brain oximetry, tissue saturation of thenar muscle and marker of AKI in blood - neutrophil gelatinase-associated lipocalin (NGAL) - measured in blood samples during the first post-op day.

Study Overview

• Status: Unknown
• Conditions: Heart Valve Diseases; Acute Kidney Injury
• Intervention / Treatment: Procedure: Open heart surgery on cardiopulmonary bypass.

Detailed Description

The day before operation, after verification of inclusion and exclusion criteria, the visiting anesthesiologist will explain to the patient the aim of the study. By signing an informed consent the patient will be recruited into the study. On the evening before operation the patient will receive the statin in a dose taken along.

In the OR the anesthesiologist will verify if creatinin and blood urea nitrogen were measured the day before operation - if not, a blood sample for the test will be obtained and sent to perform the tests.

Before induction of anesthesia a bi-spectral index (BIS) probe will be placed on the patients forehead. Above the BIS probe a INVOS(TM) probe for brain oximetry (5100 C Cerebral/Somatic Oximeter, Somanetics, Medtronic) will be placed.

Brain oximetry by near infrared saturation (NIRS) and tissue saturation on thenar muscle will be recorded before and during operation on nine timepoints.

As NIRS and thenar muscle saturation are non-routine non-invasive methods of intraoperative monitoring, patient had to sign an informed consent to participate into the study, and ethic committee approval for the study protocol was appealed and granted.

General anesthesia will be induced by: fentanyl 0.2 mg, propofol 0.5-1.5 mg/kg in bolus 200ml/godz.; and rocuronium - 0.5 mg/kg. After induction dexamethasone will be given in a dose of 0,7-1 mg/kg. For conduction of anesthesia before cardiopulmonary bypass (CPB) sevoflurane will be added to the inhaled mixture of air and oxygen. On CPB propofol will be given iv. In case of hemodynamic instability after commencing CPB, which will require catecholamines in a cumulative dose of > 1.5 standard, or in case of trouble to commence CPB, propofol will be replaced by midazolam in a dose 0.2-0.3 mg/kg/hour.

During anesthesia, first post-operative day and hospital stay a total of 278 variables will be recorded: hemodynamic parameters, iv fluid doses, inotropes, vasopressors, diuretics, urine output, transfusions, etc.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Romuald Lango, M.D., Ph.D.; Phone Number: +48583492483; Email: rlango@gumed.edu.pl
• Study Contact Backup: Name: Maciej Kowalik, M.D., Ph.D.; Phone Number: +48583492483; Email: mkowalik@gumed.edu.pl

Study Locations

• Poland
  • Pomorskie
    • Gdansk, Pomorskie, Poland, 80-211
      • Recruiting
      • Medical University of Gdańsk, Department of Cardiac Anesthesiology
      • Contact: Romuald Lango, M.D., Ph.D.; Phone Number: +48583492483; Email: rlango@gumed.edu.pl
      • Contact: Maciej Kowalik, M.D., Ph.D.; Phone Number: +48583492483; Email: mkowalik@gumed.edu.pl
      • Sub-Investigator: Wiktor Szymanowicz, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patient scheduled for elective on-bypass cardiac surgery (aortic valve surgery, mitral valve surgery with/without tricuspid valve surgery, ascending aorta surgery with/without aortic valve surgery).

Description

Inclusion Criteria:

• adult patients
• signed informed consent
• scheduled for elective on-bypass cardiac surgery (aortic valve surgery, mitral valve surgery with/without tricuspid valve surgery, ascending aorta surgery with/without aortic valve surgery).

Exclusion Criteria:

• chronic kidney insufficiency (serum creatinine >2 mg/dL)
• active infection (i.e.: endocarditis)
• shock or tissue hypoperfusion before operation (blood lactate >3 mmol/L)
• left ventricle ejection fraction <25%
• vancomycin used for infection prophylaxis (i.e.: in immunosuppressed patients)
• history of ischaemic shock

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BRAIN+THENAR MUSCLE INVOS; Patients undergoing open heart surgery on cardiopulmonary bypass.	Procedure: Open heart surgery on cardiopulmonary bypass.; Brain oximetry and tissue saturation will be measured during operation. NGAL, cystatin-C, and Acute Kidney Injury Network (AKIN) criteria of AKI will be assessed durin first post-op day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NGAL	neutrophil gelatinase-associated lipocalin (NGAL) measured in blood samples	3 hours after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NGAL on second day	neutrophil gelatinase-associated lipocalin (NGAL) measured in blood samples	second post-op day morning
Cystatin C	Cystatin-C measured in blood samples	second post-op day morning
Serum creatinine	Serum creatinine in serum	second post-op day morning
Acute renal failure	Acute renal failure requiring renal replacement therapy or AKIN stage 3	30 day / any time after operation before discharge from hospital
In hospital mortality	Death from any reason.	30 day / any time after operation before discharge from hospital

Collaborators and Investigators

• Sponsor: Medical University of Gdansk
• Investigators: Study Director: Romuald Lango, M.D., Ph.D., Medical University of Gdańsk, Department of Cardiac Anesthesiology

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: November 21, 2016
• First Submitted That Met QC Criteria: November 28, 2016
• First Posted (Estimate): December 1, 2016

Study Record Updates

• Last Update Posted (Actual): April 12, 2018
• Last Update Submitted That Met QC Criteria: April 11, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: acute kidney injury; cardiopulmonary bypass; neutrophil gelatinase-associated lipocalin; tissue hypoxia
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Wounds and Injuries; Acute Kidney Injury; Heart Valve Diseases
• Other Study ID Numbers: NKEBN/122/2014; grant ST-44 (Other Grant/Funding Number: Medical University of Gdansk)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data (IPD) may be done available to other researchers upon reasonable request directed to study director.